Siddique Abbasi is a physician-scientist who is an Executive Medical Director in the Cardiometabolic therapeutic area at Amgen. Siddique received his BA and MD from St. Louis University, graduating summa cum laude with a degree in Philosophy. He completed his internal medicine training at the University of Washington in Seattle followed by cardiovascular disease fellowship at the University of Illinois. He continued his cardiovascular training at the Brigham and Women's Hospital and Harvard Medical School, where he completed a postdoctoral research fellowship and also received a Master of Science in Epidemiology from Harvard TH Chan School of Public Health. Siddique was then appointed assistant professor at Brown University where he ran a research lab that studied the impact of obesity and diabetes on cardiovascular risk. Since joining Amgen in 2017, he has been the global development lead for programs in heart failure (omecamtiv mecarbil), lipids (Repatha), and now obesity (AMG133 and AMG786). 

Dr Zhenming Shun is the Global Head of biostatistics and data management at Daiichi-Sankyo, Inc. responsible for leading statistics, programming and data management functions to support global R&D portfolio and post-marketing activities.  Dr Shun has over 25 years of experience in various biopharmaceutical companies with increasing responsibilities. He has led development activities in various therapeutic areas including oncology and cardiovascular diseases. Dr Shun’s primary interest is in adaptive designs in clinical trials and random effect model-based methodology. Dr Shun received PhD from University of Chicago. 

Dr Harpreet Singh is a medical oncologist and the Director of the Division of Oncology 2 at the US Food and Drug Administration (FDA) and expert in both geriatric and thoracic oncology. The Division of Oncology 2 (DO2) regulates Investigational New Drug Applications (INDs), New Drug Applications (NDAs) and Biologic Licensing Applications (BLAs) for thoracic head & neck, neuro-oncology rare cancers, pediatric solid tumors. Dr Singh continues to see patients in a prostate cancer multidisciplinary clinic at the National Cancer Institute. She is native of Los Angeles and graduated from the University of California, San Diego before completing her medical degree at the University of Southern California Keck School of Medicine. She completed her internal medicine residency and geriatrics fellowship at the Los Angeles County + University of Southern California Medical Center. She then went on to the National Cancer Institute at the National Institutes of Health for a fellowship in medical oncology. She focused on tumor immunology and biology, including cancer vaccines and immunotherapy clinical trials. Dr. Singh joined the FDA as a medical officer in 2015, where she quickly established herself as a leader in geriatric oncology. She has presented research at major conferences, including the American Society for Clinical Oncology and the American Society for Hematology. Dr. Singh is an active member of the Cancer and Aging Research Group, a dynamic group of geriatric oncology researchers across the nation who work in a collaborative effort to design and implement clinical trials to improve the care of older adults with cancer. She has been working actively with ASCO and other key stakeholders to increase the evidence base for treating older adults with cancer.

Dr Aditya Rajagopal is the Co-founder and the Chief Technology Officer at Chromacode, a multiplexed molecular diagnostics company with a bioinformatics focus and pedigree from Google[x], Illumina, Luminex, and Caltech. Chromacode is transforming the multi-billion dollar molecular diagnostics industry by democratizing personalized medicine. 

Aditya is the inventor of HDPCR, ChromaCode’s core technology. Previously, he was a researcher at Google[x], where he worked on novel medical imaging methods. He has expertise in thermal engineering, digital signal processing, nano-scale electronics, low-power circuit design for implantable sensors, DNA sequencing structures and techniques, and PCR devices and applications.

Aditya is also the Executive Chairman & Co-Founder of Esperto Medical Company, a Caltech spin-out utilizing compressed sensing methods with ultrasound to continuously and non-invasively measure blood pressure. Backed by Maverick Ventures and others. Aditya received BS, MS and PhD from CalTech. 

Jaime Wheeler, MBA, CPhT is the Senior Vice President of Clinical Affairs for Transcatheter Heart Valves at Edwards Lifesciences. She has worked in both medical device and pharmaceutical research for over 25 years focusing on the strategy, design, and conduct of clinical research across various therapeutic areas including: Cardiology, Rheumatology, Pain Management, Peripheral Vascular/Embolic Protection and Structural Heart. She has managed multiple divisions and regions including an expatriate assignment in Tokyo, Japan. She was the Clinical lead on three successful Merger and Acquisition deals, the largest worth $1.5B. Ms. Wheeler holds two Bachelor of Science degrees, a Master of Business Administration degree, she was a prior Virginia State Emergency Medical Technician (EMT-B) and is a Certified Pharmacy Technician (CPhT). She currently sits on the AdvaMed Working Group for Women in Cardiovascular Device Trials, is a founding member of the MedTech Color Collaborative Community on Diversity and Inclusion in Medical Device Product Development and Clinical Research, and is a Board Member for OneOC in Santa Ana, California.

Dr Prelaj is a Medical Oncologist specializing in thoracic malignancies at the Thoracic Unit of Istituto Nazionale Tumori di Milano in Italy since 2018. She completed her residency in Medical Oncology at Sapienza University, Policlinico Umberto I Hospital in Rome, Italy. During her training, Dr Prelaj was awarded the ESMO Clinical Unit Visit in 2017 and spent time at The Christie Hospital in Manchester, collaborating with Dr. Raffaele Califano in the Lung Cancer Division from October to December 2017. Over the past seven years, her research has primarily focused on thoracic malignancies, particularly non-small cell lung cancer (NSCLC) and translational immunotherapy. Since May 2019, she has also directed her research towards the fields of bioengineering and artificial intelligence (AI) and is currently pursuing a Ph.D. at Politecnico di Milano’s Department of Electronics, Informatics, and Bioengineering. She serves as the principal investigator for multiple international clinical trials and is actively involved in coordinating various national and international grant applications in the field of thoracic malignancies and immunotherapy. As the head of the AI-ON-Lab (Artificial Intelligence for Oncology Lab) at Istituto Nazionale Tumori of Milano, she is responsible for leading research and development in the application of AI in oncology. Dr Prelaj is an ESMO, ASCO, AACR, IASLC and AIOM member and faculty at many congresses on AI.

Sunil Gupta is an CDISC SME and works at PointCross.  Sunil is also an international speaker, best-selling author of five SAS books and a global SAS developer and CDISC SME and corporate trainer. He is an advocate of CDISC automation and standardisation, with over 25 years of experience in the pharmaceutical industry. Sunil is currently teaching Practical R for SAS Programmers, a CDISC online class at the University of California at San Diego and classes on data science using SAS at UCLA and UCSD Extension. In 2019, Sunil published his fifth book, Clinical Data Quality Checks for CDISC Compliance Using SAS and, in 2011, launched his unique SAS mentoring blog, SASSavvy.com, for smarter SAS searches and R-Guru.com for R Programming. Sunil has an MS in Bioengineering from Clemson University and a BS in Applied Mathematics from the College of Charleston. 

Bhavin Busa is recognized as a thought leader in the areas of data standards, programming and regulatory submission. He is very passionate about leveraging standards and technology to expedite data review, analysis and submission processes. In line with his passion, Bhavin recently co-founded Clymb Clinical, a startup that is driving innovation and revolutionizing the clinical data industry through implementation of technology and open-source solutions. He devotes much of his time outside of his day job to volunteer with PHUSE and CDISC. He holds a position on the PHUSE Working Group Leadership Committee and serves on the CDISC Open-Source Alliance (COSA) Board. Additionally, Bhavin serves as a CDISC ARS Product Owner/Co-lead and is slated to be the Chair of upcoming PHUSE US Connect 2024.  

After obtaining master degree from mathematical statistics at Charles University in Prague (Czech rep., Europe), Tomas worked on various projects involving all aspects of data science (data collection, analysis, presentation/visualisation) and many aspects of SW development (programming, analysis, management). Currently, Tomas leads a EU biostatistics group of Clinical Affairs, Transcatheter Heart Valve unit at Edwards Lifesciences. He is based in Prague.

Simon Heap works as Senior Consultant at Phastar, Copenhagen. Simon has 20+ years of experience with data handling and programming and 15+ years of experience with business intelligence tools from Qlik. Simon’s experience stems from clients in several industries, and he joined Phastar in 2022 to focus on clients and solutions within the pharmaceutical industry. Simon has a BA in musicology, aesthetics and cultural studies from Aarhus University, Denmark, and further studies within strategy and business from the IT University of Copenhagen. Phastar is a Qlik Sense Elite Partner and Simon holds the Qlik Sense Data Architect and Qlik Sense Business Analyst certifications.

Brian Ramos is a Director of Statistical Programming at Edwards Lifesciences leading the programming efforts in support of Edwards’ PASCAL Transcatheter Valve Repair System. He has over 20 years of industry experience leading and supporting all aspects of statistical programming with several successful PMA submissions under his belt. As a big proponent of automation, he constantly seeks solutions to increase programming efficiencies to make programmer’s lives easier. He has previously presented at PharmaSUG and is happy to be presenting for the first time at OCBS. He is a native of Southern California, received his degrees from the University of California, Los Angeles, and doesn’t see himself leaving the area for any place else.

Li Huang is a principal biostatistician in PHASTAR.  She received DDS from Hubei Medical University (China), Master of Science in Dentistry from National University of Singapore (NUS), Master of Science in Applied Statistics from California State University, Long Beach (CSULB). She was rewarded Scholarship of scientific research in NUS. She has worked in the projects related with genetics, clinical trial and real-word evidence statistical analysis more than ten years in academical department at UCIrvine and pharmaceutical companies. She published six papers in the past 4 years. She currently holds an important role as newsletter editor in American Statistical Association Orange County/Long Beach Chapter (OCLBASA). She is interested in statistical models and data analysis. She also attends R-ladies and SoCal RUG conference.  

Jeff is passionate about designing and developing breakthrough software applications with intuitive UI for life science industry. As the co-founder and CEO of RealtimeCRO and the President of Viitai, he has been at the forefront of creating efficient and compliant software applications that accelerate the drug development process. His team’s innovations are highly regarded in the industry, influencing daily operations at prominent biotech firms, CROs, and research institutions.

Previously, Jeff served as the head of IT at Ultragenyx Pharmaceutical, where he built the entire IT division from the ground up, reporting directly to the CEO. At BioMarin Pharmaceutical, which he joined in 2007, Jeff oversaw information technology across all DevOps functions. Together with the CMO, he developed an application that Google requested to make it its first case study for the biopharmaceutical domain.

Jeff started his career in life science at Parexel in 2001. There, he crafted specialized systems hosting clinical trial data for hundreds of sponsors. From 2005-2007, he was the technical lead for Parexel’s biggest IT project ever, PMED. Before Parexel, Jeff was at Compaq developing software applications for internal content search/indexing. Jeff can be reached at jcao@realtimecro.com.

Anthony Chow is Executive Director, Data Science, at CDISC. He is a multi-faceted professional with a proven track record in developing international standards, implementing software, managing projects, and providing consultancy. His professional experience spans multiple industries over the 30 years of his career. He earned a degree in Computer Science and is currently pursuing his master’s in healthcare informatics. Anthony frequents professional conferences, volunteers, gives workshops, and presents on contemporary topics. In his free time, he enjoys nature photography and cooking for friends and family.

Bruce Ho, Ph. D is a Data Scientist  with experiences in multiple  domains. He started his career as an academic researcher, cumulating in a faculty appoint at Harvard Medical School, and over 100 scientific publications. Since joining the industry, Bruce developed enterprise scale applications for top technology companies  including TeraData, Amazon, Life Technologies, etc., led  product development for a few startups, and consulted  as an AI specialist with UST-Global, OrangePeople and  Bigr.io.  

Currently, Bruce focuses on application of AI in  healthcare. His expertise includes Deep Learning ,  Generative AI, and out of distribution predictions, with  coverage over nlp, computer vision, predictive  maintenance, anomaly detection, etc. His interest in  healthcare led to launching of a startup, Bayezene AI,  with a mission to accelerated clinical trials.  

Bruce has a strong statistics background, having  obtained his BA in physics from MIT and PhD in Applied  Physics from Caltech and is conversant with  mathematical formulation of solutions to real world  problems. 

As Executive Vice President and the Head of US HEOR at Lumanity, Jonathan Kowalski is responsible for accelerating the expansion of HEOR services in the US to help clients succeed in early pipeline value strategy and evidence planning, health technology assessment, new product payer engagement and launch excellence, and post-approval product differentiation. 

Jonathan joined Lumanity in September 2020 following more than 20 years at Allergan (Irvine, California) where he held a number of US and Global HEOR, market access and health-policy leadership roles including Vice President and Head, US Health Outcomes and Value; and Vice President, US HEOR and Global HEOR Initiatives. Jonathan also held increasing roles of responsibility in leading global HEOR teams and strategy for key franchises, including ophthalmology, urology, medical dermatology and facial aesthetics.

Jonathan holds a Bachelor of Science degree in Pharmacy and a Doctor of Pharmacy degree from the University of Wisconsin-Madison, and a Masters of Science degree in pharmaceutical sciences with an emphasis in pharmaceutical economics, outcomes research, and health policy from the University of Arizona.

Dr. Damla Senturk, PhD, a Biostatistics professor since 2011, became the Chair on July 1, 2023. Her research specializes in developing statistical methods for complex data analysis applied to health challenges like Autism Spectrum Disorder (ASD) and end-stage kidney disease (ESKD). She has led NIH-funded research groups for over a decade, holds an ISI membership, and is an ASA fellow. You can read more about Dr. Damla Senturk on her profile page.

Dr. Wei (Vivian) Zhuang is a Staff Fellow of the Division of Bioinformatics and Biostatistics at FDA’s National Center for Toxicological Research (NCTR). Her current primary research interest is to design new scientifically and statistically sound methods to analyze data resulting from advanced technologies, e.g., liquid biopsies, for biomarker detection and early diagnosis. She has been assigned or invited to work on projects on nephrotoxicity, cardiotoxicity, carcinogenicity, neuronal toxicity, drug induced liver injury, and statistical methods for whole-transcriptome sequencing data analysis. Her work and research will help advance regulatory science through new tools and approaches required to support public health.

Currently, Dr. Zhuang serves as a principal investigator (PI) of a biostatistical project to leverage qPCR (quantitative real-time polymerase chain reaction) technology for biomarker detection in liquid biopsy and other body fluid tests (NCTR protocol E0772101). She is also a co-PI or collaborator of several ongoing NCTR protocols on microRNA biomarkers, mutation detection, genome editing, drug-induced liver toxicity, and chemotherapeutic resistance in ovarian cancer. In addition, she serves as a biostatistician in an OECD (Organization for Economic Co-operation and Development) Expert Workgroup for versions of the Ames assay, which is a test on whether a given chemical can cause mutations in the DNA of a test organism. 

A clinical research and development executive with over 20 years of experience in drug, device, and imaging diagnostic agent development and a proven track record of successful execution of clinical development and post-marketing activities in early-stage and pivotal clinical trials leading to NDA submissions, approvals, and market launch. A result-oriented team leader who provides directions to the team and strategy for the clinical development plan and execution to meet corporate objectives.

My experience and accomplishments highlight my expertise in biostatistics, particularly in the design and analysis of clinical trials, my leadership abilities, and my commitment to advancing medical research.

I currently serve as a lead biostatistician at JnJ MedTech CSS group, where I play a crucial role in providing statistical support for the design and execution of clinical trials within both Mentor and Coherex franchises. In my position, I not only offer statistical guidance to junior statisticians but also spearheaded the development of the first summer internship program for CSS. Additionally, I have successfully enhanced the processes for study routine reports and SOPs, ensuring greater efficiency and accuracy. Moreover, I have been a key statistician for a PMA submission of the Mentor team, contributing to the successful completion of an important regulatory milestone. 

Prior to joining JnJ, I dedicated five years to working as a statistician at COG, specializing in pediatric oncology clinical trial designs. During this time, I gained expertise in various areas such as sample size calculation and conditional power analysis through simulation. Furthermore, I simultaneously handled statistical analyses and prepared publications for five projects that were part of the Malignant Germ Cell Tumors International Collaborative Consortium. 

Before transitioning to industry, I had a rewarding six-year tenure as a faculty member in the Biostatistics Department at the Keck School of Medicine at USC. During this time, my primary research focus was on phase 3 pediatric oncology RCTs with COG. In this role, I collaborated closely with esteemed research clinicians to independently design 13 superiority and non-inferiority group sequential design trials. Additionally, I successfully managed a team of three statisticians, mentored seven MS students, and taught statistics to MD students, imparting my knowledge and expertise to the next generation of researchers. My contributions to the field of biostatistics are reflected in my extensive publication record, which includes over 27 collaborative papers. 

I am a hybrid between an Environmental Scientist and a Biostatistician. I received my Master's in Biology from California State University Long Beach in 2012 with an emphasis in Marine Ecology. Though I love Marine Science I have developed an interest in Biostatistics along the way and subsequently completed a Master's in Applied Statistics. I currently work for Hoag Memorial Hospital Presbyterian as a Data Scientist/Statistician in the Strategic Analytics Department, supporting our partners hospital-wide with their data analytics needs.

I have been working here for about 2 years and it has been a great learning experience. My educational background stems from UC Riverside receiving both BS and MS degrees in Statistics. I grew up in San Diego, went to college in Riverside, and currently work in Irvine, CA. Along with my aspiration to be competent as a Statistical Programmer, I also strive to be impactful beyond my role at work. Aside from jogging, you can find me enjoying a cup of coffee or milk tea in my spare time.

Dr. Shen is a senior statistical advisor to numerous biopharmaceutical companies to support their drug development programs. He is Vice President and head of Biometrics Services at WuXi Clinical. 

Dr. Shen is a fellow of the American Statistical Association. He has authored many articles on statistical methodology and their applications to drug development. 

Dr. Shen was Vice President at Amylin Pharmaceuticals leading their entire clinical development organization in the development and approval of several first-in-class medicines. Following the acquisition of Amylin by Bristol Myers Squibb in 2013, he co-founded Pharmapace, Inc., a biometrics consulting and CRO company serving the biopharma industry, and served as its President and CEO. Pharmapace was later acquired by WuXi AppTec in 2019. 

Dr. Shen obtained his Ph.D. in Statistics from the University of California at Berkeley and both BS and MS degrees in mathematics/probability theory from Beijing University in China.